SENSOR DEVELOPMENT AND VALIDATION
RELEASE DATE: February 25, 2002
RFA: RFA-EB—02-002
PARTICIPATING INSTITUTES AND CENTERS (ICs):
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
(http://www.nibib.nih.gov)
National Human Genome Research Institute (NHGRI)
(http://www.nhgri.nih.gov/)
National Institute on Deafness and Communication Disorders (NIDCD)
(http://www.nidcd.nih.gov/)
National Institute of Dental and Craniofacial Research (NIDCR)
(http://www.nidcr.nih.gov/)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
(http://www.niddk.nih.gov)
LETTER OF INTENT RECEIPT DATE: March 29, 2002
APPLICATION RECEIPT DATE: April 24, 2002
THIS RFA CONTAINS THE FOLLOWING INFORMATION
o Purpose of this RFA
o Research Objectives
o Mechanism(s) of Support
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations:
PURPOSE OF THIS RFA
The National Institute of Biomedical Imaging and Bioengineering
(NIBIB), the National Human Genome Research Institute (NHGRI)the
National Institute on Deafness and Communication Disorders (NIDCD), the
National Institute of Dental and Craniofacial Research (NIDCR), and the
National Institute of Diabetes and Digestive and Kidney Diseases
(NIDDK) invite applications for NIH Research Project Grants (R01) or
Phased Innovation Awards (R21/R33) in sensor development and
validation. NIBIB is soliciting research that can be applied to
multiple biological or disease processes. The NIDCD is interested in
sensor systems pertaining to the auditory, vestibular, olfactory, taste,
voice, speech and language neural and sensory systems. The NIDCR is
interested in the development of sensor system for simultaneous multi-
analyte detection in saliva and other oral fluids. NIDDK is soliciting
projects focused on continuous and/or noninvasive glucose measurement,
as well as research to incorporate glucose sensors into closed-loop
insulin delivery systems for management of diabetes. The purpose of
this Request for Applications (RFA) is to support innovative basic and
applied research targeted at sensor development including sensor
arrays, their biointerfaces, quality control issues, validation and
data interpretation. Multidisciplinary approaches are encouraged that
involve disciplines such as materials engineering, biochemistry,
mathematics, computer science, electrical engineering, physiology,
medicine, bioengineering and physics.
Biorecognition elements in combination with various transduction
methods have enabled major advancements in the development of sensors
and chips. In addition, recent enhancements have enabled the merging of
functions for computation, communication and power source together with
sensor and actuator. To move these technologies into the clinical
situation, certain impediments must be addressed. In particular, this
initiative encourages research to address:
o integration of sensors to obtain multiplexed functionality,
o sensor interface and related algorithm development to relate sensor
output to physiologically relevant or clinically relevant parameters,
o biofouling of sensors, and
o sensor system and data validation.
RESEARCH OBJECTIVES
Biology and medicine have gained enormous insight into the life process
by discovery, development and application of sensors. Such sensors
have enabled discoveries relating to DNA, RNA and protein synthesis,
cell organelle function, tissue organization and organ system
integration in normal and diseased states. This information has
enabled researchers to develop new methods for the prevention,
diagnosis and treatment of diseases. While these developments have
been extraordinary, future breakthroughs will depend on improvements in
sensor technology. In particular, sensor advancements will be achieved
with methods to prevent biofouling, to integrate sensors to obtain
multiplexed functionality, to develop algorithms to relate sensor
output to physiologically relevant or clinically relevant parameters
and validation of sensors systems.
Biological sensor systems have demonstrated the complexity and the
simplicity of nature. The olfactory system reveals a strategy that is
complementary to the conventional chemical sensing approach but
involves the use of sensor arrays. Olfactory receptors are not highly
selective toward specific analytes but rather one receptor responds to
many analytes and many receptors respond to any given analyte. Thus,
sensor arrays do not require the high specificity of an individual
sensor. Identification of an analyte is determined by a distinct
pattern of responses over the sensor array (fingerprint) rather then
the response of a single sensor element. Sensor arrays would be a
significant improvement over conventional sensors.
Sensors that are placed in a solution or a human will have a corruption
of the signal and will eventually fail due to biofouling. Biofouling
is the rapid accumulation of adsorbed material on the working surface
of the sensor. This problem makes long-term monitoring difficult and
requires frequent maintenance operations and probe replacement.
Biofouling is found to occur in every monitoring technique that
operates in situ (electrochemical, optical electrical, thermal, etc.).
Techniques to overcome biofouling are urgently needed.
Validation of sensor measurements is an integral step in the
application of sensor technology. The sensor measurements must be
shown to be consistent even under changing conditions of operation,
e.g., in vivo, temperature, pH, ion concentration, etc. While sensor
redundancy is one method for addressing validation, this method has
disadvantages. In general any validation method must address the
sensor function in real time. Once the sensor data has been validated,
it is essential to relate the sensor output to a physiologically
relevant or clinically meaningful value(s). The relationship between
the sensor measurement and the clinical parameter(s) must be clearly
defined. Algorithm(s) must be developed to relate sensor measurements
to these parameters. For example, the relationship between a sensor
output and blood glucose must be known in order to regulate insulin
delivery in response to a glucose measurement made in the interstitium.
Utilization of sensors without validation and without a clear
understanding of the relationship of the data to the parameter(s) of
interest is inappropriate application of sensor technology.
The objectives and scope of this initiative are to support basic and
applied research for the discovery of novel sensor technology and the
enhancement of sensor utilization in research, clinical investigations
and disease management. Irrespective of a sensor"s detection system or
the measured parameter(s), certain basic issues will have to be
addressed for successful sensor advances. These issues include
biofouling, data validation and algorithm determination. Innovative
approaches to address any or all of these issues are within the scope
of this initiative. In addition, or alternatively, utilization of
novel sensor array technologies would be appropriate. Research topics
might include but are not limited to the following:
o Construction of sensor arrays,
o Development of multi-modality sensor arrays,
o Development of biomimetic materials that will reduce or prevent biofouling,
o Design of a sensor surface that is impregnated with compounds to
alter the immune response or enhance wound repair,
o Development of robust data validation methods that are applicable to
a wide range of sensor modalities,
o Development of approaches to relate sensor output to clinical parameters,
o Design of models to relate the sensor"s physical response
characteristics to data integrity,
o Development of sensor quality control systems in real time,
o Utilization of prediction models to measure sensor drift or identify
incorrect data,
o Construction of the computer interface, sensor control software, and
data processing software to link sensor array output to a clinical parameter,
o Development of biological based high throughput sensor technologies
using organism specific markers for the detection of middle ear infections,
o Development of electrostimulatory prostheses capable of sensing head
acceleration forces to improve the balance of vestibular-deficient individuals,
o Development and enhancement of sensor technology for the improved
detection of odor and taste substances,
o Development of sensor arrays for simultaneous analyte detection in
saliva and other oral fluids,
o Development and evaluation of novel continuous and/or noninvasive
glucose sensors, and
o Development of approaches to link glucose sensing to insulin systems
in a closed-loop system for the treatment of diabetes
o Development of the neural tissue and circuitry hardware interface(s)
to improve amplification and transmission of sound and speech.
The overall objective of this RFA is to provide flexible funding
mechanisms to support the research activities required to discover,
develop and validate innovative sensor approaches.
MECHANISM OF SUPPORT
This RFA will use the NIH Research Project Grant (R01) and Phased
Innovation Award (R21/R33) mechanisms. As an applicant you will be
solely responsible for planning, directing, and executing the proposed
project. This RFA is a one-time solicitation. Future unsolicited,
competing-continuation applications based on this project will compete
with all investigator-initiated applications and will be reviewed
according to the customary peer review procedures. The anticipated
award date is September 30, 2002.
This RFA uses just-in-time concepts. Applications for the R01
mechanism use the modular as well as the non-modular budgeting formats
(see http://grants.nih.gov/grants/funding/modular/modular.htm).
Specifically, if you are submitting a R01 application with direct costs
in each year of $250,000 or less, the modular format should be used.
Otherwise follow the instructions for non-modular research grant
applications. For this RFA, applications for R21/R33 grants should use
the detailed budget (non-modular) format only.
The R01 mechanism is recommended for applications that emphasize basic
research on sensor arrays, glucose sensors, their biointerfaces,
quality control issues and validation. Research periods associated with
the R01 proposals are limited to five years.
The R21/R33 Phased Innovation Award is recommended for system
engineering approaches such as the development and integration of
sensors that can be applied to multiple biological or disease
processes, incorporation of glucose sensors into closed-loop systems,
or partnerships with industry for technology development and
dissemination. The combined R21/R33 application offers two advantages
over the regular application process – (1) single submission and
evaluation of both the R21 and R33 phases as one application and (2)
minimal or no funding gap between the R21 and R33 phases. A single
application for the combined R21 and R33 phases with a total period of
up to five years is required for this initiative. The R21 phase
supports exploratory or developmental research aimed at proof-of-
principle for high-risk projects where preliminary data is not
available. An R21 application can be for one to two years with a
maximum budget request of $150,000 direct costs per year. The R33
mechanism supports the second phase of the innovative exploratory or
developmental research initiated under the R21 mechanism. A R33
application can be for one to four years with a maximum budget request
of $500,000 direct costs per year. Transition from the R21 to the R33
phase is dependent on successful completion of milestones specified in
the R21 application as determined by program staff in the context of
peer review recommendations.
The R21 application must include milestones that will be used to judge
the success of the proposed exploratory research. The Phased
Innovation Award application must have a section titled "Milestones" at
the end of the Research Plan for the R21 application. This section
must propose well-defined, quantifiable milestones for the completion
of the R21 phase, a discussion of the suitability of the proposed
milestones for assessing the success of the R21 research, and a
discussion of the implications of successful completion of these
milestones for the R33 phase.
FUNDS AVAILABLE
The NIBIB, NHGRI, NIDCD, NIDCR and NIDDK intend to commit approximately
$6.9 million in FY 2002 to fund new grants in response to this RFA.
Because the nature and scope of the proposed research will vary from
application to application, it is anticipated that the size and
duration of each award will also vary. Although the FY 2002 financial
plans of the NIBIB, the NIDCD and the NIDDK provide support for this
program, awards pursuant to the RFA are contingent upon the
availability of funds and the receipt of a sufficient number of
meritorious applications. At this time, it is not known if this RFA
will be reissued.
ELIGIBLE INSTITUTIONS
You may submit an application if your institution has any of the
following characteristics:
o For-profit or non-profit organization
o Public or private institutions such as universities, colleges,
hospitals, and laboratories
o National laboratories
o Units of state and local governments
o Eligible agencies of the Federal government
o Domestic or foreign
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS
Any individual with the skills, knowledge, and resources necessary to
carry out the proposed research is invited to work with their
institution to develop an application for support. Individuals from
underrepresented racial and ethnic groups as well as individuals with
disabilities are always encouraged to apply for NIH programs.
WHERE TO SEND INQUIRIES
We encourage inquiries concerning this RFA and welcome the opportunity
to answer questions from potential applicants. Inquiries may fall into
three areas: scientific/research, peer review, and financial or grants
management issues:
o Direct your questions about scientific/research issues to:
Joan T. Harmon, Ph.D.
Acting Director
Division of Bioengineering
National Institute of Biomedical Imaging and Bioengineering
Building 31, Room 1B37
Bethesda, MD 20892
Telephone: (301) 451-6772
FAX: (301) 480-4515
Email: joan_harmon@nih.gov
Jeffery A. Schloss, Ph.D.
Division of Extramural Research
National Human Genome Research Institute
Building 31, Room B2.B07
Bethesda, MD 20892-2033
Telephone: (301)496-7531
FAX: (301)480-2770
Email: jeff_schloss@nih.gov
Nancy L. Freeman, Ph.D.
Scientific Program Director
National Institutes of Health
National Institute on Deafness and Other Communication Disorders
Executive Plaza South-400C
6120 Executive Blvd. MSC-7180
Bethesda, MD 20892-7180
Telephone: (301) 402-3458
Fax: (301) 402-6251
Email: nancy_freeman@NIH.gov
Maren R. Laughlin, Ph.D.
Director, Metabolism Program
National Institute of Diabetes and Digestive and Kidney Diseases
2 Democracy Plaza, 6707 Democracy Blvd., Room 6101, MSC 5460
Bethesda, MD 20892-5460
Telephone: (301)594-8802
FAX: (301) 480-3503
Email: Maren.Laughlin@nih.gov
Eleni Kousvelari, DDS, D.Sc.
Biotechnology and Biomaterials Program
Cellular & Molecular Biology, Physiology
& Biotechnology Branch
Division of Basic and Translational Sciences
National Institute of Dental and Craniofacial Research
Building 45 Room 4AN-18A
Bethesda, MD 20892
Telephone: (301) 594-2427
FAX: (301) 480-8318
Email: eleni.kousvelari@nih.gov
o Direct your questions about peer review issues to:
Calbert Laing, Ph.D.
Chief
Immunological Sciences Integrated Review Group
Center for Scientific Review
Building RKL2, Room 4210
Bethesda, MD 20892
Telephone: (301) 435-1221
FAX: (301) 480-4045
Email: laingc@csr.nih.gov
o Direct your questions about financial or grants management matters to:
Ms. Annette Hanopole
Grants Management Officer
National Institute of Biomedical Imaging and Bioengineering
Building 31, Room 1B37
Bethesda, MD 20892-2077
Telephone: 301-451-6768
Fax: 301-480-4515
Email: hanopola@nibib.nih.gov
Jean Cahill
Grants Administration Branch
National Human Genome Research Institute
Building 31, Room B2.B34
Bethesda, MD 20892-2031
Telephone: (301) 402-0733
FAX: (301) 402-1951
Email: jc166o@nih.gov
Sara Stone
Chief, Grants Management Branch
NIH/NIDCD
Executive Plaza South, Room 400B
6120 Executive Boulevard, MSC-7180
Bethesda, MD 20892
Telephone: (301) 402-0909
Fax: (301) 402-1758
Email: sara_stone@nih.gov
Ms. Denise Payne
Grants Management Specialist
National Institute of Diabetes and Digestive and Kidney Diseases
2 Democracy Plaza, 6707 Democracy Blvd., Room 733, MSC 5456
Bethesda, MD 20892-5456
Telephone: (301)594-8845
FAX: (301) 480-3504
Email: payned@extra.niddk.nih.gov
H. George Hausch, Ph.D.
Acting Director,
Division of Extramural Activities
National Institute of Dental and Craniofacial Research
National Institutes of Health
45 Center Drive, Room 4AN-44F
Bethesda, MD 20892-6402
Telephone: (301) 594-2904
FAX: (301) 480-8303
Email: George.Hausch@nih.gov
LETTER OF INTENT
Prospective applicants are asked to submit a letter of intent that
includes the following information:
o Descriptive title of the proposed research
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel
o Participating institutions
o Number and title of this RFA
Although a letter of intent is not required, is not binding, and does
not enter into the review of a subsequent application, the information
that it contains allows NIBIB and CSR staff to estimate the potential
review workload and plan the review.
The letter of intent is to be sent by the date listed at the beginning
of this document. It is preferred that the letter of intent be sent
electronically to noi@nibib.nih.gov. If necessary, the letter of
intent can be sent by regular mail to Dr. Joan T. Harmon, listed in the
WHERE TO SEND INQUIREIES section of this announcement.
SUBMITTING AN APPLICATION
Applications must be prepared using the PHS 398 research grant
application instructions and forms (rev. 5/2001). The PHS 398 is
available at http://grants.nih.gov/grants/funding/phs398/phs398.html in
an interactive format. For further assistance contact GrantsInfo,
Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.
SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications
requesting up to $250,000 per year in direct costs must be submitted in
a modular grant format. The modular grant format simplifies the
preparation of the budget in these applications by limiting the level
of budgetary detail. Applicants request direct costs in $25,000
modules. Section C of the research grant application instructions for
the PHS 398 (rev. 5/2001) at
http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-
by-step guidance for preparing modular grants. Additional information
on modular grants is available at
http://grants.nih.gov/grants/funding/modular/modular.htm.
USING THE RFA LABEL: The RFA label available in the PHS 398 (rev.
5/2001) application form must be affixed to the bottom of the face page
of the application. Type the RFA number on the label. Failure to use
this label could result in delayed processing of the application such
that it may not reach the review committee in time for review. In
addition, the RFA title and number must be typed on line 2 of the face
page of the application form and the YES box must be marked. The RFA
label is also available at:
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.
SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten
original of the application, including the Checklist, and five signed,
photocopies, in one package to:
Center For Scientific Review
National Institutes Of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710
Bethesda, MD 20817 (for express/courier service)
APPLICATION PROCESSING: Applications must be received by the
application receipt date listed in the heading of this RFA. If an
application is received after that date, it will be returned to the
applicant without review.
The Center for Scientific Review (CSR) will not accept any application
in response to this RFA that is essentially the same as one currently
pending initial review, unless the applicant withdraws the pending
application. The CSR will not accept any application that is
essentially the same as one already reviewed. This does not preclude
the submission of substantial revisions of applications already
reviewed, but such applications must include an Introduction addressing
the previous critique.
PEER REVIEW PROCESS
Upon receipt, applications will be reviewed for completeness by the CSR
and responsiveness by the NIBIB. Incomplete applications will be
returned to the applicant without further consideration. And, if the
application is not responsive to the RFA, CSR staff may contact the
applicant to determine whether to return the application to the
applicant or submit it for review in competition with unsolicited
applications at the next appropriate NIH review cycle.
Applications that are complete and responsive to the RFA will be
evaluated for scientific and technical merit by an appropriate peer
review group convened by the CSR in accordance with the review criteria
stated below. As part of the initial merit review, all applications will:
o Receive a written critique
o Undergo a process in which only those applications deemed to have the
highest scientific merit, generally the top half of the applications
under review, will be discussed and assigned a priority score
o Receive a second level review by the appropriate Institute
Advisory Council.
REVIEW CRITERIA
The goals of NIH-supported research are to advance our understanding of
biological systems, improve the control of disease, and enhance health.
In the written comments, reviewers will be asked to discuss the
following aspects of your application in order to judge the likelihood
that the proposed research will have a substantial impact on the
pursuit of these goals:
o Significance
o Approach
o Innovation
o Investigator
o Environment
The scientific review group will address and consider each of these
criteria in assigning your application"s overall score, weighting them
as appropriate for each application. Your application does not need to
be strong in all categories to be judged likely to have major
scientific impact and thus deserve a high priority score. For example,
you may propose to carry out important work that by its nature is not
innovative but is essential to move a field forward.
(1) SIGNIFICANCE: Does your study address an important problem? If the
aims of your application are achieved, how do they advance scientific
knowledge? What will be the effect of these studies on the concepts or
methods that drive this field? To what degree does the technology
support the needs for research on biological or disease processes?
(2) APPROACH: Are the conceptual framework, design, and methods
adequately developed, well integrated, and appropriate for (l) cross-
cutting fundamental discovery (R01) or (2) technology and tool
development (R21/R33)? Does the applicant acknowledge potential
problem areas and consider alternative tactics? If appropriate, what
is the time frame for developing the proposed technologies or tools,
and what is the suitability of this time frame for meeting the
community"s needs? How easy will it be to use the proposed technology
or tools? Are the plans adequate for integrating the proposed
technology as an effective solution for implementation and
dissemination? If industrial partnerships are proposed, how will they
facilitate and complement the technology and tool development?
(3) INNOVATION: Does the project address discovery or technology/tool
development that represents innovation for the field? Does the project
challenge existing paradigms or employ novel concepts, approaches, or
methods? What are the innovative applications of the proposed
fundamental discovery, technology, or tools?
(4) INVESTIGATOR: Does the principal investigator possess appropriate
experience and capabilities to direct and carry out this work? Is the
experience level of the principal investigator, other researchers, or
collaborators appropriate for the proposed effort?
(5) ENVIRONMENT: Does the scientific environment in which your work
will be done contribute to the probability of success? Do the proposed
experiments take advantage of unique features of the scientific
environment or employ useful collaborative arrangements? Is there
evidence of institutional support or collaborative agreements?
ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your
application will also be reviewed with respect to the following:
o PROTECTIONS: The adequacy of the proposed protection for humans,
animals, or the environment, to the extent they may be adversely
affected by the project proposed in the application.
o INCLUSION: The adequacy of plans to include subjects from both
genders, all racial and ethnic groups (and subgroups), and children as
appropriate for the scientific goals of the research. Plans for the
recruitment and retention of subjects will also be evaluated. (See
Inclusion Criteria included in the section on Federal Citations, below)
o BUDGET: The reasonableness of the proposed budget and the requested
period of support in relation to the proposed research.
o MILESTONES FOR COMBINED R21/R33 APPLICATIONS: For the R21/R33
applications, how appropriate are the proposed milestones for
evaluating the demonstration of feasibility for the R21 effort and
transition to the R33 development phase?
For R21/R33 Phased Innovation Award applications, the scientific review
group will evaluate the specific goals of each phase and the
feasibility milestones that would justify progression to the R33 phase.
A single priority score will be assigned to each scored application.
As with any grant application, the scientific review group has the
option of recommending support for a shorter duration than that
requested by the applicant, and basing the final merit rating on the
recommended portion of the application. This may result in a
recommendation that only the R21 phase of the combined R21/R33
application be supported based on the relative merit of the two
research plans, adequacy of the milestones for determining success of
the R21 feasibility studies, and capacity to provide easily assessed
justification for progression to the R33 phase without further review.
The scientific review group may recommend modifications to or the
addition of milestones. Deletion of the R33 phase by the review panel
or inadequate milestones may affect the rating of the application.
RECEIPT AND REVIEW SCHEDULE
Letter of Intent Receipt Date: March 29, 2002
Application Receipt Date: April 24, 2002
Peer Review Date: June/July 2002
Council Review: September 2002
Earliest Anticipated Start Date: September 30, 2002
AWARD CRITERIA
Award criteria that will be used to make award decisions include:
o Scientific merit (as determined by peer review)
o Availability of funds
o Programmatic priorities.
REQUIRED FEDERAL CITATIONS
INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy
of the NIH that women and members of minority groups and their sub-
populations must be included in all NIH-supported clinical research
projects unless a clear and compelling justification is provided
indicating that inclusion is inappropriate with respect to the health of
the subjects or the purpose of the research. This policy results from
the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43).
All investigators proposing clinical research should read the AMENDMENT
"NIH Guidelines for Inclusion of Women and Minorities as Subjects in
Clinical Research - Amended, October, 2001," published in the NIH Guide
for Grants and Contracts on October 9, 2001
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html),
a complete copy of the updated Guidelines are available at
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH
definition of clinical research, updated racial and ethnic categories
in compliance with the new OMB standards, clarification of language
governing NIH-defined Phase III clinical trials consistent with the new
PHS Form 398, and updated roles and responsibilities of NIH staff and
the extramural community. The policy continues to require for all NIH-
defined Phase III clinical trials that: a) all applications or
proposals and/or protocols must provide a description of plans to
conduct analyses, as appropriate, to address differences by sex/gender
and/or racial/ethnic groups, including subgroups if applicable, and b)
investigators must report annual accrual and progress in conducting
analyses, as appropriate, by sex/gender and/or racial/ethnic
group differences.
INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN
SUBJECTS: The NIH maintains a policy that children (i.e., individuals
under the age of 21) must be included in all human subjects research,
conducted or supported by the NIH, unless there are scientific and
ethical reasons not to include them. This policy applies to all initial
(Type 1) applications submitted for receipt dates after October 1, 1998.
All investigators proposing research involving human subjects should
read the "NIH Policy and Guidelines" on the inclusion of children as
participants in research involving human subjects that is available at
http://grants.nih.gov/grants/funding/children/children.htm.
REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH
policy requires education on the protection of human subject
participants for all investigators submitting NIH proposals for research
involving human subjects. You will find this policy announcement in the
NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of
research on hESCs can be found at
http://grants.nih.gov/grants/stem_cells.htm and at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.
Only research using hESC lines that are registered in the NIH Human
Embryonic Stem Cell Registry will be eligible for Federal funding (see
http://escr.nih.gov). It is the responsibility of the applicant to
provide the official NIH identifier(s)for the hESC line(s)to be used in
the proposed research. Applications that do not provide this
information will be returned without review.
PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT:
The Office of Management and Budget (OMB) Circular A-110 has been
revised to provide public access to research data through the Freedom of
Information Act (FOIA) under some circumstances. Data that are (1)
first produced in a project that is supported in whole or in part with
Federal funds and (2) cited publicly and officially by a Federal agency
in support of an action that has the force and effect of law (i.e., a
regulation) may be accessed through FOIA. It is important for
applicants to understand the basic scope of this amendment. NIH has
provided guidance at
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this initiative in a
public archive, which can provide protections for the data and manage
the distribution for an indefinite period of time. If so, the
application should include a description of the archiving plan in the
study design and include information about this in the budget
justification section of the application. In addition, applicants
should think about how to structure informed consent statements and
other human subjects procedures given the potential for wider use of
data collected under this award.
URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and
proposals for NIH funding must be self-contained within specified page
limitations. Unless otherwise specified in an NIH solicitation, Internet
addresses (URLs) should not be used to provide information necessary to
the review because reviewers are under no obligation to view the
Internet sites. Furthermore, we caution reviewers that their anonymity
may be compromised when they directly access an Internet site.
HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to
achieving the health promotion and disease prevention objectives of
"Healthy People 2010," a PHS-led national activity for setting priority
areas. This RFA is related to one or more of the priority areas.
Potential applicants may obtain a copy of "Healthy People 2010" at
http://www.health.gov/healthypeople.
AUTHORITY AND REGULATIONS: This program is described in the Catalog of
Federal Domestic Assistance No. 93.287 (NIBIB), No. 93.172 (NHGRI), No.
93.173 (NIDCD), No. 93.173 (NIDCR) and No. 93.847 (NIDDK) and is not
subject to the intergovernmental review requirements of Executive Order
12372 or Health Systems Agency review. Awards are made under
authorization of Sections 301 and 405 of the Public Health Service Act
as amended (42 USC 241 and 284) and administered under NIH grants
policies described at http://grants.nih.gov/grants/policy/policy.htm
and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92.
The PHS strongly encourages all grant recipients to provide a smoke-
free workplace and discourage the use of all tobacco products. In
addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits
smoking in certain facilities (or in some cases, any portion of a
facility) in which regular or routine education, library, day care,
health care, or early childhood development services are provided to
children. This is consistent with the PHS mission to protect and
advance the physical and mental health of the American people.